Digital diagnostics – developing tools for supporting clinical decisions by integrating various diagnostic data

Proposals should develop tools, platforms or services that will use information provided by most relevant diagnostic means for a particular area, resulting in an accurate, detailed, structured, systemic and prioritised assessment of the health status in a patient. The proposed solutions should integrate various data sources such as medical records, in vitro and/or in vivo diagnostics, medical imaging, -omics data, functional tests (lab-on-a-chip) etc., while taking into account the actual needs of healthcare practitioners, and should be tested and validated in real-life settings in pilot centres, facilitating future Health Technology Assessment. These tools/platforms/services should contribute to improving diagnosis and clinical decision, not only integrate existing data, and should involve intelligent human-computer interface solutions to facilitate its daily use in clinical practice. Any medical data relevant for a particular disease (textual data, numerical measurements, recorded signals, images etc.) may be considered. The aim is to steer the development of solutions towards concrete patient and public sector needs, having the citizen and healthcare providers at the centre. Careful attention should be paid to appropriately addressing ethical and legal concerns, providing adequate information to health professionals and patients to support informed decisions, and ensuring data safety and privacy, in line with existing European and international standards and legislation. Gender and sex differences should be taken into consideration when relevant.

The Commission considers that proposals requesting a contribution from the EU of between EUR 8 and 15 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting different amounts.

The availability of appropriate decision support tools for healthcare practitioners can promote uptake of personalised medicine in health care. There is a need to carry out research activities aiming to develop and validate such decision tools that would integrate available and/or emerging diagnostic means for the area concerned, enabling increased precision of diagnostics and clinical decision making. On-going progress in the fields of bioinformatics and biostatistics, advanced analytical tools (e.g. machine learning) up to Artificial Intelligence (AI) solutions, should make possible the development of devices, platforms or novel approaches leading to highly personalised diagnosis, based on the integration of data available from various sources. The ultimate result would be a detailed health status assessment from a multitude of viewpoints, in a systemic way and easy to use for clinical purposes, leading to better diagnostic accuracy, increased effectiveness and efficiency of treatments. Novel hardware enabling truly innovative, integrative diagnostic platforms can also be considered.

• Increase EU's capacity to innovate in the area of medical instruments technologies through the development of new diagnostic tools, platforms or services integrating various diagnostic data and providing quick, detailed, accurate and highly personalised diagnostics for optimal decision in clinical practice.
• Improve the quality and sustainability of healthcare systems through quicker and more encompassing diagnosis of medical conditions, leading to quicker and better clinical decisions and timely delivery of effective personalised treatments, with reduction of errors and delays (and costs associated to them).
• Contribute to the growth of the European diagnostics sector, in particular for SMEs.
• Reinforce EU's role among world leaders in the production of medical diagnostic devices.